Not Applicable
Not Applicable
A stent is a radially expandable endoprosthesis which is adapted to be implanted in a body lumen. Stents are typically used in the treatment of atherosclerotic stenosis in blood vessels and the like to reinforce body vessels and to prevent restenosis following angioplasty in the vascular system. They have also been implanted in urinary tracts, bile ducts and other bodily lumen. They may be self-expanding or expanded by an internal radial force, such as when mounted on a balloon.
Delivery and implantation of a stent is accomplished by disposing the stent about a distal portion of the catheter, percutaneously inserting the distal portion of the catheter in a bodily vessel, advancing the catheter in the bodily lumen to a desired location, expanding the stent and removing the catheter from the lumen. In the case of a balloon expandable stent, the stent is mounted about a balloon disposed on the catheter and expanded by inflating the balloon. The balloon may then be deflated and the catheter withdrawn. In the case of a self-expanding stent, the stent may be held in place on the catheter via a retractable sheath. When the stent is in a desired bodily location, the sheath may be withdrawn allowing the stent to self-expand.
In the past, stents have been generally tubular but have been composed of many configurations and have been made of many materials, including metals and plastic. Ordinary metals such as stainless steel have been used as have shape memory metals such as Nitinol and the like. Stents have also been made of bio-absorbable plastic materials. Stents have been formed from wire, tube stock, etc. Stents have also been made from sheets of material which are rolled.
A number of techniques have been suggested for the fabrication of stents from sheets and tubes. One such technique involves laser cutting a pattern into a sheet of material and rolling the sheet into a tube or directly laser cutting the desired pattern into a tube. Other techniques involve cutting a desired pattern into a sheet or a tube via chemical etching or electrical discharge machining.
Laser cutting of stents has been described in a number of publications including U.S. Pat. No. 5,780,807 to Saunders, U.S. Pat. No. 5,922,005 to Richter and U.S. Pat. No. 5,906,759 to Richter. Other references wherein laser cutting of stents is described include: U.S. Pat. No. 5,514,154, U.S. Pat. No. 5,759,192, U.S. Pat. No. 6,131,266 and U.S. Pat. No. 6,197,048.
A typical laser cutting system relies on a laser to produce a beam which is conditioned as necessary via an optical unit and focused into a spot beam which is impinged against a hollow tube that is to become the stent. The hollow tube may be moved via a rotational motor drive and linear motion drive.
An example of a conventional laser for cutting a stent is a highly focused pulsed Nd:YAG laser which has a pulse duration in the range of approximately 0.1 to 20 milliseconds. This is a long pulse time for cutting and characteristically produces a relatively large melt zone and heat affected zone (HAZ) on the metal. The conventional laser cutting process typically results in the formation of melt dross on the inside edge of the cut tube. This dross must be cleaned off in subsequent processes.
Non-uniformities in the material such as differences in wall thickness create different heat rises in the material and lead to variations in cut quality. Laser parameters have to be re-tuned for optimum cutting for tubes with slightly different wall thicknesses adding to the downtime of the process and reducing the yield. An additional drawback of cutting hollow tubes to produce stents by laser is that due to the extremely small diameter of the tubes, it is possible to damage the inner wall of the opposite side of the tube due to the inability of the laser to defocus to a level such that beam intensity is adequately low enough to prevent damage.
While laser energy has often been utilized for cutting stents, such laser energy has also been utilized for processing hypotubes and other substantially tubular bodies, such as may be used for producing catheters, balloons, etc. For example, in some cases laser energy may be utilized to create microfeatures in/on the surface of the tube being processed or to provide ports or other features through a tube wall. In processing hypotubes with laser energy, the potential for damage to the tube interior is also a problem.
In a recent development, cutting and processing systems have been developed that incorporate a water column and laser. SYNOVA Inc., of Lausanne, Switzerland, has developed a laser-microjet that uses a laser beam that is contained within a water jet as a parallel beam, similar in principle to an optical fiber.
The SYNOVA laser-microjet relies on low pressure water column to contain the laser, to reduce force applied to the work piece, to act as a cooling mechanism and to remove cutting debris. A laser-microjet as presently known however, may still include the potential to damage the inside surface of the hollow tube being cut or processed due to the inability of the laser to be properly defocused before damage can result.
In light of the above a need exists to provide a laser cutting/processing system wherein the potential for damage to the inside surface of the hollow tube being cut or processed is minimized or alleviated completely.
All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety.
Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below.
A brief abstract of the technical disclosure in the specification is provided as well only for the purposes of complying with 37 C.F.R. 1.72. The abstract is not intended to be used for interpreting the scope of the claims.
The present invention is directed to a variety of embodiments. In at least one embodiment the invention is directed to a system for cutting and/or processing a hollow tube. The system of the present embodiment utilizes a hybrid laser/water jet mechanism to direct laser energy to the tube. The system also employs an mechanism for injecting a media such as gas, fluid, etc, through the hollow tube in order to disrupt and/or prevent the formation of the water column within the tube. Such a disruption, results in deflection of the laser energy, thereby preventing the laser energy from reaching, and thus damaging, the opposite inside wall of the tube.
In at least one embodiment the hollow tube is a tube of a material suitable for constructing a stent, such a tube may be at least partially constructed from, stainless steel, nickel, titanium, palladium, gold, tantalum, or any other metal or alloy thereof suitable for constructing a stent. In at least one embodiment the tube is at least partially constructed from a polymer substance.
In at least one embodiment the hollow tube is a tube of material suitable for constructing a tubular medical device, or component thereof In the such an embodiment the processed tube may be utilized as, or a portion of: a hypotube, a catheter, a balloon, a sock, a sleeve, an embolic protection filter, etc.
In at least one embodiment the media being injected through the hollow tube is a fluid or gas. In some embodiments the media is injected through the tube at a pressure less than the pressure of the water jet being applied to the tube wall. In some embodiments it may be beneficial to provide the injected media with a degree of turbulence. In at least one embodiment turbulence may be induced by providing bubbles or micro-bubbles in the fluid media. In some embodiments the fluid media may include a dispersement of metallic or other absorptive and/or reflective particles to further disrupt the laser energy.
In at least one embodiment the media being passed through the tube is a high viscosity material or a material having a viscosity different than the viscosity of the water jet being applied to the tube wall.
In at least one embodiment the media that is passed through the tube functions as an oxidizer, cleaner, polishing agent, pretreatment, etc.
In at least one embodiment a secondary member is inserted into the tube during cutting or processing. The secondary member may be a rod, ribbon, a secondary hollow tube, etc. The secondary member and the tube may define an annulus through which media may continue to be passed.
In some embodiments the tube being processed is positioned in a vertical orientation during processing and/or cutting.
In some embodiments the tube being processed is positioned in a horizontal orientation during processing and/or cutting.